12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BonOs Inject, Pedicle screw kits, Cement pusher
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112519·BARRON VACUUM TREPHINE 8.0MM
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AUTO*THERM 395, MODEL ME 395
FDA 510(k)
FDA Class 2
·Physical Medicine
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·February 7, 2014
VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code DKJ·October 8, 2008
INNOVA 2121
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS·Product code MQB·August 5, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Malfunction
·COOK INC·Product code MIH·July 15, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012